Study Design

We will evaluate the impact of pharmacologic enhancement of effective sleep with nightly eszopiclone (taken before bedtime for 1 week, home environment) on glycemic profiles (continuous glucose monitoring, 72 hrs) in prediabetics and diabetics compared to pretreatment baseline. The dose of eszopiclone will be the lowest tolerated dose (1-3 mg) via dose escalation and side effect profile assessment.

eszopiclone
Lunesta

Eszopiclone at a dose of 1-3 mg (lowest tolerated dose, as determined using a dose escalation schedule and side effect profile)will be taken 30 minutes before bedtime for one week.

Primary Outcomes

Measure

change in continuous glucose profile

time frame:
comparing 72 hours of baseline and after 1 week of eszopiclone

Secondary Outcomes

Measure

change in Sleep effectiveness biomarkers

time frame:
nightly comparing baseline with post-7 nights of eszopiclone

Additional Information

Official title

Sleep Effectiveness and Insulin and Glucose Homeostasis

Principal investigator

Melanie Pogach, MD

Description

Evidence from experimental studies supports the hypothesis that fragmented or insufficient
sleep contributes to impaired glucose and insulin homeostasis. The sleep spectrogram, an
EEG-independent measure of sleep effectiveness, maps coupled oscillations of heart rate
variability and ECG-derived respiration. In a sample of non-diabetic subjects with and
without sleep apnea, we previously explored the association between ECG-spectrogram derived
biomarkers and glucose metabolism and found that the marker of effective sleep, High
Frequency Coupling (HFC), is associated with reduced diabetes risk (increased Disposition
Index). HFC is also enhanced by sedative medications (unpublished data). In this study we
will 1.) explore the relationship between sleep effectiveness and insulin sensitivity across
the sleep period, by frequently sampling glucose and insulin during nocturnal
polysomnography in healthy and prediabetic subjects; and 2.) evaluate the impact of
pharmacologic enhancement of effective sleep with nightly eszopiclone (1 week, home
environment) on glycemic profiles (continuous glucose monitoring, 72 hrs) in prediabetics
and diabetics compared to pretreatment baseline. We expect that desirable glycemic profiles
will correlate with the spectrographic marker of effective sleep while undesirable glucose
profiles will correlate with the marker of ineffective sleep. Using pharmacologic
enhancement of effective sleep, we expect to demonstrate improvement in glycemic profiles in
prediabetic and diabetic subjects compared to pre-treatment baseline.

Trial information was received from ClinicalTrials.gov and was last updated in December 2015.